J&J, Gilead HIV Drug Wins FDA Approval

The Food and Drug Administration cleared the therapy that
combines New Brunswick, New Jersey-based J&J’s Edurant and
Gilead’s Truvada, Foster City, California-based Gilead said
today in a statement. A single, or fixed-dose, daily tablet
simplifies HIV therapy, said John Martin, Gilead’s chairman and
chief executive officer, in the statement.

The combination product, called Complera, is expected to
generate $567 million in revenue in 2013, said Joel Sendek, an
analyst with Lazard Capital Markets in New York. He called the
drug a “catalyst” for Gilead, the world’s biggest maker of
AIDS drugs, in a July 27 note to clients.

“The concept of a single-tablet regimen has become a goal
in HIV drug development and the standard of care in medical
practice in the United States,” Tony Mills, an investigator in
Complera studies, said in the Gilead statement. “Given its
efficacy, safety and convenience, the availability of Complera
represents an exciting milestone in addressing the individual
needs of patients new to HIV therapy.”

About 1.2 million people in the U.S. have HIV with about
48,100 new patients contracting the virus in 2009, the Centers
for Disease Control and Prevention said Aug. 4 in a report.

Gilead’s Pill

Gilead now sells the only single-pill HIV regimen, Atripla,
a triple-drug combination approved in 2006 that includes Sustiva
from Bristol-Myers Squibb Co. (BMY) Atripla was Gilead’s top seller in
2010, generating $2.9 billion.

Gilead and J&J announced an agreement June 28 to develop a
fixed-dose HIV treatment combining Gilead’s experimental
cobicistat and Prezista from J&J. Cobicistat increases blood
levels of certain HIV medicines to allow for once-daily dosing,
according to a statement from Gilead.

The companies also said they are negotiating the terms of
an agreement to develop a single-tablet regimen combining
Prezista with Gilead’s Emtriva, cobicistat and investigational
GS 7340.

Truvada is Gilead’s second-highest selling drug behind its
Atripla with $2.6 billion in sales last year, according to
Bloomberg data. The FDA approved Edurant May 20, in combination
with other antiretroviral agents, for patients who have never
taken HIV treatment before.

The companies originally filed an application for the
Truvada and Edurant combination Nov. 23. The FDA told the drug
manufacturers Jan. 25 the agency needed more information, which
Gilead and J&J included when they refiled their application Feb.
10, according to a statement from Gilead.